CompletedPhase 1

Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

United States18 participantsStarted 2021-01-26

Plain-language summary

Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 70 with moderate to severe comorbidity or vulnerability to cisplatin, defined as having one or more of the following conditions within 4 week of registration:
✓. Modified Charlson Comorbidity Index ≥ 1
✓. Adult Comorbidity Evaluation-27 (ACE-27) Index ≥ 1
✓. ω score \< 0.80
✓. Geriatric 8 (G-8) score ≤ 14
✓. Cancer and Aging Research Group (CARG) Toxicity Score ≥ 30%
✓. Cumulative Illness Rating Scale-Geriatric (CIRS-G) Score ≥ 4
✓. Age \< 70 with severe comorbidity or vulnerability to cisplatin, defined as having two or more of the following conditions within 4 weeks prior to registration:

What they're measuring

Incidence of Dose-Limiting Toxicities at 50 Gy With Concurrent Atezolizumab

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 50 Gy

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 55 Gy

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 60 Gy

Timeframe: 12 months

Maximum Tolerated Radiation Dose

Timeframe: 12 months

Trial details

NCT IDNCT04477759

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-08

Results submitted2025-04-08

View on ClinicalTrials.gov More Head and Neck Neoplasm trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 70 with moderate to severe comorbidity or vulnerability to cisplatin, defined as having one or more of the following conditions within 4 week of registration:
✓. Modified Charlson Comorbidity Index ≥ 1
✓. Adult Comorbidity Evaluation-27 (ACE-27) Index ≥ 1
✓. ω score \< 0.80
✓. Geriatric 8 (G-8) score ≤ 14
✓. Cancer and Aging Research Group (CARG) Toxicity Score ≥ 30%
✓. Cumulative Illness Rating Scale-Geriatric (CIRS-G) Score ≥ 4
✓. Age \< 70 with severe comorbidity or vulnerability to cisplatin, defined as having two or more of the following conditions within 4 weeks prior to registration:

What they're measuring

Incidence of Dose-Limiting Toxicities at 50 Gy With Concurrent Atezolizumab

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 50 Gy

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 55 Gy

Timeframe: 12 months

Incidence of Dose-Limiting Toxicities at 60 Gy

Timeframe: 12 months

Maximum Tolerated Radiation Dose

Timeframe: 12 months